Identity
- Trade Name
- ELMED INCORPORATED FDA UDI
- Generic Name
- Craniofacial rongeur, reusable FDA UDI
- Device Name
- KERRISON RONGEUR, MICRO 11" (275MM), 1MM, 40 DEG UP SST FDA UDI
- Model / Reference
- STSS111MM40 FDA UDI
- Description
- KERRISON RONGEUR, MICRO 11" (275MM), 1MM, 40 DEG UP SST FDA UDI
Identifiers
- Catalog Number
- STSS111MM40 FDA UDI
- Primary DI / UDI-DI
- 00198506056185 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Craniofacial rongeur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial rongeur, reusable
Elmed Incorporated by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial rongeur, reusable.
- IVD Rongeur — Koros USA, Inc. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Wiggins Medical — EBNER MEDICAL LLC · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Wiggins Medical — EBNER MEDICAL LLC · Class I
- BEAR — Bear-Ent, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI 7bb4fbc8-e6f9-428f-97e9-e5b7e165a072 35 fields · synced Jun 8, 2026